How would DNDN be able to enroll enough volunteers to finish the 500 patients clinical trial?
If Provenge was available, why would a patient risk taking the placebo rather then then the real drug?
Wouldn't the only solution be for the FDA to give an approvable letter and grant approval only once the trial has been completed?
If so, how long a delay would that entail? Certainly not 2010! I'm guessing 3 to 6 months tops. Any ideas?
Is the completion of this trial primordial for the authorization to market and distribute Provenge or could the FDA grant immediate approval and ask for other data in parallel to continuous follow-up monitoring? TIA
I don't know if Dr. Von E was refering to the completion of tests, but i do remember him saying something about allowing new drugs to be avaiable as fast as possible and monitering them after there release.
I'm sorry, that question really makes no sense what so ever. Drugs with approved status and, studies using these drugs, are not mutually exclusive. Why would a study be impossible once a drug is approved? Makes no sense.
Thanks, I'll keep googling for precedents but the idea of an immediate approval with follow-up feedback monitoring would make sense if FDA wants the product on the market which I believe they do. The fact that it is so safe is also a great encouragement!
In the meantime, would someone please refute the arguments provided by this article shorting DNDN?
I suspect the author is distorting the facts but at this point, I do not have enough knowledge to distinguish the accurate from the inaccurate. Here's the link:
I will try with my limited knowledge and with a heavy investment in DNDN, and picking up more later.
First of all, this was written prior to the committee's recommendation, so it makes the article moot, and he is obviously wrong.
I think this should be enough to refute it:
"Disclosure: Author has a short position in DNDN"
DNDN has a patent on a totally revolutionary process in battling cancer. Not all people enjoy revolution but it is necessary in the evolution of medical treatments.
I remind everyone of the scientist who contended that H Pylori was the cause of stomach ulcers. Lots of people laughed at him. He was an outcast, rejected by the scientific community. Lots of money was made on relieving ulcer symptoms. When he gave himself stomach ulcers with H Pylori, and then sure that ailment with antibiotics, things got a lot more interesting for him. Now antibiotics is standard treament for stomach ulcers and you really seldom hear about anyone having suffered greatly from it.
Nothing but a slime ball, as all shorts are, who could care less about the health and welfare of men all over the world. He just wants his money.
Again, this cancer treatment process, when approved by the FDA, can and will be used as a first line of defense against Prostate Cancer. It will be the first thing that is done when it is found that the PSA levels have been elevated.
In the trials, the people who recieved this treatment process had already exhausted all the toxic chemicals that could be used to battle the cancer.
So the candidates in the trials were already seriously (!) compromised in health by traditional chemo and some radiation methods.
AND I have always said that "chemo kills!". Chemo kills more clients than cancer does.
Radiation CAUSES cancer. What makes people think that it can battle cancer?
It is a good question. It is possible they'll delay approval pending full enrollment in the trial (no way do they wait for results in 2010), but your concern about keeping patients in the trial is spot on. OTOH, are we going to doom all those placebo patients, and all the ones who won't enroll in trials, just so we can get more efficacy data on something we already believe is safe and effective? The more reasonable approach is to just move on with the research, starting trials that use Provenge and taxotere in various combinations and finishing the existing trial with the patients they have, possibly modifying it to allow all patients to receive Provenge and using historical controls.
Approve Provenge to move into phase IV post marketing trials, and everyone benefits. A delay hurts too many patients and also hurts the pipeline. The evidence is sufficient for approval now.
Wouldn't the Advisory Panel have considered this Question, and thought the better solution would be to approve it. Besides I am sure that the approval will be for LIMITED use in controlled situations and not for general use, while the research and data collection continues.
I was thinking the same thing last night, but i would assume they use the real patients and study effects on them instead. They still have phase 3 trial advertised on their website, if it disappears or changes it could be a good sign.
This a real question, not bashing. This must have been brought up at some point but I can't find the answer among so many posts.
Any opinions as to how DNDN could enroll the 100 missing volunteers if Provenge were available on the market?